The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Dapagliflozin and Metformin Hydrochloride
Dapagliflozin and Metformin Hydrochloride · DAPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 · Tablet, Extended Release · Oral · Macleods Pharmaceuticals Limited
NDC 33342-0408-06 · 3 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for dapagliflozin and metformin hydrochloride (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- analysis · label · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA211559
- TE code
- AB
- Approval date
- Apr 6, 2026
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Dapagliflozin and Metformin Hydrochloride (Tablet, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Lupin Pharmaceuticals, Inc. | DAPAGLIFLOZIN 10 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | DAPAGLIFLOZIN 10 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | DAPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | DAPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | DAPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | DAPAGLIFLOZIN 10 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | DAPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | DAPAGLIFLOZIN 10 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Dapagliflozin and Metformin Hydrochloride — NDC 33342-0408-06," retrieved September 3, 2026, https://drugdashboards.com/drug/33342040806.
Free to cite with attribution — see how the data is put together.